Scynexis' Brexafemme (ibrexafungerp tablets) Receives the US FDA's Approval as the First Oral Non-Azole Treatment for Vaginal Yeast Infections
Shots:
- The approval is based on results from two P-III studies evaluating ibrexafungerp which demonstrates efficacy and a favorable tolerability profile in women with VVC
- Scynexis has partnered with Amplity to support US commercial launch of Brexafemme which is expected to available in H2’21 while the therapy is also being evaluated in CANDLE study for the prevention of recurrent VVC & company plans to submit a sNDA in H1’22
- The therapy has received both QIDP and FT designations from FDA to prevent VVC. Scynexis continues to advance its pipeline of ibrexafungerp indications to create a long-lasting antifungal franchise in both hospital and community settings
Ref: SCYNEXIS | Image: SCYNEXIS
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